Condition category
Musculoskeletal Diseases
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
01/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Nuria Navarro Coy

ORCID ID

Contact details

Senior Trial Manager
Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom

Additional identifiers

EudraCT number

2007-004757-28

ClinicalTrials.gov number

NCT01106079

Protocol/serial number

5221

Study information

Scientific title

A randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis

Acronym

TICOPA

Study hypothesis

Tight control versus standard care of early psoriatic arthritis (less than 24 months disease duration).

Ethics approval

Northern and Yorkshire Research Ethics Committee (REC), 01/02/2008, ref: 07/H0903/72

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Intervention

A total of 206 patients will be randomised on an equal basis to receive either intensive management (4 weekly review) or standard care (12 weekly review). Each patient will participate in the study for 48 weeks. Those subjects randomised to the tight control arm will be reviewed every 4 weeks (by the PI at each site or a designated researcher) and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate.

Follow up length: 12 months
Study entry: Single Randomisation only

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

The percentage of study patients achieving an ACR 20 response at 12 months.

Secondary outcome measures

Changes in clinical response over 6 and 12 months

Overall trial start date

01/05/2008

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consultant diagnosis of psoriatic arthritis (PsA)
2. Disease duration less than 24 months
3. Active disease
4. Ages greater than 18 years, either sex
5. Able to consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 206; UK Sample Size: 206

Participant exclusion criteria

1. Previous treatment with disease modifying anti-rheumatic drugs (DMARDs) for PsA
2. Under the age of 18 years
3. Pregnant women or planning pregnancy
4. Recent use of investigational drug

Recruitment start date

01/05/2008

Recruitment end date

01/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

-
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk

Funders

Funder type

Industry

Funder name

Arthritis Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Pfizer UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23517506
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26433318

Publication citations

  1. Protocol

    Coates LC, Navarro-Coy N, Brown SR, Brown S, McParland L, Collier H, Skinner E, Law J, Moverley A, Pavitt S, Hulme C, Emery P, Conaghan PG, Helliwell PS, The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis., BMC Musculoskelet Disord, 2013, 14, 101, doi: 10.1186/1471-2474-14-101.

  2. Results

    Coates LC, Moverley AR, McParland L, Brown S, Navarro-Coy N, O'Dwyer JL, Meads DM, Emery P, Conaghan PG, Helliwell PS, Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial, Lancet, 2015, doi: 10.1016/S0140-6736(15)00347-5.

Additional files

Editorial Notes

01/02/2016: Publication reference added.